Rapido Medical Laser

Primary DI
08059340291083
Brand
Rapido Medical Laser
Company
MEDENCY SRL
Model
Rapido Podia
Catalog number
MD.RAPIDO.29.04.POD
Device description
"Wavelength: 810nm/1064nm, Max power: 10WThe model Rapido Podia of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in podiatry, including the treatment of onychomycosis and diabetic foot wounds. It’s also intended for traumatology and pain therapy. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts."
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240543000Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Medency S.R.L.2024-10-24GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059340291083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059340291083080593402910838059340291083

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal160 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal160 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
436042800
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059340290086Rapido Medical LaserRapido PodiaMD.RAPIDO.03.07.POD2026-05-06
08059340290246Rapido Medical LaserRapido DermaMD.RAPIDO.02.04.DER_012026-05-06
08059340290253Rapido Medical LaserRapido Derma MD.RAPIDO.10.07.DER_012026-05-06
08059340290260Rapido Medical LaserRapido Derma MD.RAPIDO.16.04.DER_012026-05-06
08059340290468Rapido Medical LaserRapido MEDMD.RAPIDO.10.07.SUR2026-05-06
08059340290475Rapido Medical LaserRapido MEDMD.RAPIDO.02.04.SUR 2026-05-06
08059340290499Rapido Medical LaserRapido ENTMD.RAPIDO.06.02.ENT 2026-05-06
08059340290505Rapido Medical LaserRapido ENTMD.RAPIDO.06.04.ENT2026-05-06
08059340290512Rapido Medical LaserRapido ENTMD.RAPIDO.01.03.ENT2026-05-06
08059340290536Rapido Medical LaserRapido DermaMD.RAPIDO.02.04.DER_022026-05-06
08059340290543Rapido Medical LaserRapido DermaMD.RAPIDO.10.07.DER_022026-05-06
08059340290550Rapido Medical LaserRapido Derma MD.RAPIDO.16.04.DER_02 2026-05-06
08059340291076Rapido Medical LaserRapido MEDMD.RAPIDO.28.04.SUR2026-05-06
08059340290000Primo Dental LaserPrimoMD.PRIMO.A.02.04.DEN2024-04-10
08059340290017Primo Dental LaserPrimoMD.PRIMO.A.04.04.DEN2024-04-10
08059340290024Primo Dental LaserPrimo KomfortMD.PRIMO.D.01.03.DEN2024-04-10
08059340290031Primo Dental LaserPrimo LiteMD.PRIMO.B.02.01.DEN2024-04-10
08059340290048Primo Dental LaserPrimo BlueMD.PRIMO.E.06.02.DEN2024-04-10
08059340290055Primo Dental LaserPrimo TriploMD.PRIMO.C.18.04.DEN2024-04-10
08059340290062Primo Dental LaserPrimo TriploMD.PRIMO.C.17.04.DEN2024-04-10

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